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Local Field Potentials in Dystonia

Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

NCT ID: NCT07309133

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Deep Brain Stimulation System (device)
How long the study runs
Study runs about 39 months (dates as stated)
About the drug or intervention
Deep Brain Stimulation System — device: The Medtronic Percept™ DBS system will be used as part of standard clinical care for dystonia.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
25
Started
2025-09-04
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for dystonia
  • • Clinical study - 25 participants
  • • The goal of this clinical trial is to learn whether local field potential (LFP) signals recorded from the globus pallidus interna (GPi) using the Medtronic Percept™ deep brain stimulation (DBS) device can help optimize DBS programming for people with dystonia

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with dystonia

Where?

  • • Newcastle upon Tyne - Clinical Ageing Research Unit,

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this clinical trial is to learn whether local field potential (LFP) signals recorded from the globus pallidus interna (GPi) using the Medtronic Percept™ deep brain stimulation (DBS) device can help optimize DBS programming for people with dystonia. The study will also explore whether LFP patterns can serve as a biomarker of disease activity and predict treatment response. The main questions it aims to answer are: Do LFP peaks in the alpha-theta range reliably correlate with dystonia severity and clinical characteristics? Can LFP-based programming achieve similar or better clinical outcomes compared to traditional programming methods? How do LFP profiles change with stimulation and other treatments such as botulinum toxin or oral medications? Researchers will compare two programming approaches: Traditional programming based on clinical assessment and imaging. LFP-guided programming based on the site and characteristics of LFP peaks Participants will: Undergo DBS surgery for dystonia as part of standard clinical care. Attend regular follow-up visits for DBS programming and outcome assessments. Complete clinical rating scales for dystonia severity, quality of life, cognition, and mood. Take part in neurophysiological assessments, including surface EMG, EEG, and reaction time tasks. Have LFP recordings collected using the Medtronic Percept™ device during clinic visits and, where possible, at home using device sensing features. This study will help determine whether LFP analysis can shorten the time to optimal DBS settings and improve outcomes for people with dystonia.

More detail

Dystonia is a disabling movement disorder characterized by sustained or intermittent muscle contractions that cause abnormal postures and movements. Deep brain stimulation (DBS) of the globus pallidus interna (GPi) is an established treatment for patients who do not respond adequately to first-line therapies such as botulinum toxin. However, clinical response to DBS in dystonia is highly variable, and optimization of stimulation settings often requires months of trial and error. This delay can prolong disability and increase healthcare burden. Local field potentials (LFPs) are neural signals recorded from implanted DBS electrodes. In Parkinson's disease, LFP analysis has been used to guide programming and develop adaptive stimulation strategies. In dystonia, early studies suggest that low-frequency LFP peaks (typically in the alpha-theta range) may correlate with disease severity and optimal stimulation sites, but these findings have been limited to short-term recordings using externalized leads. The Medtronic Percept™ DBS system now allows chronic sensing of LFPs during routine clinical care, creating an opportunity to validate these observations and assess their clinical utility. This single-site, prospective study will evaluate whether LFP profiles recorded from the GPi can guide DBS programming in patients with primary dystonia. The study includes an internal pilot phase followed by two main cohorts. Cohort 2 will undergo traditional programming based on clinical assessment and imaging, with LFP recordings collected at each visit. Cohort 3 will use an LFP-guided approach, selecting contacts and stimulation parameters based on the site and characteristics of LFP peaks. Participants will be followed for up to 12 months, with blinded video assessments and standardized rating scales to compare outcomes between programming strategies. Neurophysiological measures such as surface electromyography (EMG), electroencephalography (EEG), and reaction time tasks will also be collected to explore mechanistic links between stimulation and motor control. The study aims to determine whether LFP analysis can shorten the time to optimal DBS settings and improve clinical outcomes compared to traditional methods. If successful, this approach could inform future development of adaptive DBS systems for dystonia, reducing variability in care and improving patient quality of life.

DystoniaDystonia, FocalDystonia, Primary

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age 18 years or older at screening.
  • ✓Clear clinical diagnosis of primary dystonia (idiopathic or genetic forms).
  • ✓Candidate for GPi DBS surgery for dystonia treatment.
  • ✓Able to provide agreement to take part.

Who cannot take part

  • ✗Significant neurological or psychiatric disorder (including dementia) that would interfere with outcome evaluation.
  • ✗Participation in a therapeutic research trial within the last year.
  • ✗Diagnosis of functional (psychogenic) dystonia.
See the full criteria
Inclusion Criteria: * Age 18 years or older at screening. * Clear clinical diagnosis of primary dystonia (idiopathic or genetic forms). * Candidate for GPi DBS surgery for dystonia treatment. * Able to provide informed consent. Exclusion Criteria: * Significant neurological or psychiatric disorder (including dementia) that would interfere with outcome evaluation. * Participation in a therapeutic research trial within the last year. * Diagnosis of functional (psychogenic) dystonia.

Where Is This Study? (1 UK site)

Clinical Ageing Research Unit,

Newcastle upon Tyne NE4 6BE, United Kingdom

Recruiting
Site contact (verified)
David Ledingham, MA, MBBSPrincipal Investigator
David Ledingham, MA, MBBS+441912336161david.ledingham1@nhs.net

How to Get in Touch

David Ledingham, MA, MBBS

Sponsor contact

CONTACT

+441912826161 david.ledingham1@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-11